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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2017-003114-10
    Sponsor's Protocol Code Number:NI-0501-09
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-09-03
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-003114-10
    A.3Full title of the trial
    An Open-label, Single Arm, Multicenter Study to Broaden Access to Emapalumab, an Anti-Interferon Gamma (Anti-IFNγ) Monoclonal Antibody, and to Assess its Efficacy, Safety, Impact on Quality of Life, and Long-term Outcome in Pediatric Patients with Primary Hemophagocytic Lymphohistiocytosis
    Studio in aperto, a braccio singolo, multicentrico, per ampliare l'accesso ad emapalumab, un anticorpo monoclonale anti-interferone γ, e per valutarne la sua efficacia, sicurezza, impatto sulla Qualità di Vita, e outcome a lungo termine in pazienti pediatrici con linfoistiocitosi emofagocitica primaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study conducted in several Countries, to give access to emapalumab, and to study how efficacious and safe is in children with primary Hemophagocytic Lymphohistiocytosis (pHLH)
    Studio condotto in vari Paesi per ampliare l'accesso ad emapalumab e studiare quanto sia efficace e sicuro nei bambini con linfoistiocitosi emofagocitica primaria (pHLH)
    A.4.1Sponsor's protocol code numberNI-0501-09
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01818492
    A.5.4Other Identifiers
    Name:US IND numberNumber:111015
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/358/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovimmune S.A.
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovimmune S.A.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovimmune SA
    B.5.2Functional name of contact pointIsabelle Fournet
    B.5.3 Address:
    B.5.3.1Street Address14 Chemin des Aulx
    B.5.3.2Town/ cityPlan-les-Ouates
    B.5.3.3Post code1228
    B.5.4Telephone number+4122 593 51 58
    B.5.5Fax number+4122 5938280
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/10/749
    D.3 Description of the IMP
    D.3.1Product nameEmapalumab
    D.3.2Product code NI-0501
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEMAPALUMAB
    D.3.9.2Current sponsor codeNI-0501
    D.3.9.3Other descriptive nameFully human anti-interferon gamma monoclonal antibody
    D.3.9.4EV Substance CodeSUB188645
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Hemophagocytic Lymphohistiocytosis (pHLH)
    Linfoistiocitosi emofagocitica primaria (pHLH)
    E.1.1.1Medical condition in easily understood language
    A rare, life-threatening condition affecting predominantly children. The disease is characterized by uncontrolled inflammation.
    Malattia rara e pericolosa per la vita che colpisce principalmente i bambini. La malattia è caratterizzata da un’infiammazione incontrollata
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071583
    E.1.2Term Haemophagocytic lymphohistiocytosis
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To gather additional safety and efficacy data on emapalumab in pHLH patients.
    • Aquisire ulteriori dati sull’efficacia e la sicurezza di emapalumab in pazienti affetti da pHLH
    E.2.2Secondary objectives of the trial
    • To assess a starting dose of emapalumab of 3 mg/kg.
    • To assess the impact of emapalumab on Quality of Life (QOL).
    • To gather additional evidence on the long-term outcome of pHLH patients treated with emapalumab.
    • To further evaluate the pharmacokinetic (PK) profile of emapalumab in pHLH patients.
    • To further evaluate the pharmacodynamic (PD) effects (levels of circulating Total IFNγ and biomarkers of its neutralization, namely CXCL9 and CXCL10).
    • To assess the profile of other relevant HLH biomarkers, e.g., sCD25 and other exploratory biomarkers.
    •To monitor for potential occurrence of anti-drug antibodies (ADAs).
    • Valutare una dose iniziale di emapalumab pari a 3 mg/kg;
    • Valutare l’impatto di emapalumab sulla qualità di vita (Quality Of Life, QOL);
    • Acquisire ulteriore evidenza dell’outcome a lungo termine dei pazienti affetti da pHLH trattati con emapalumab;
    • Valutare ulteriormente il profilo farmacocinetico (Pharmacokinetics, PK) di emapalumab nei pazienti affetti da pHLH;
    • Valutare ulteriormente gli effetti farmacodinamici (Pharmacodynamics, PD) (livelli di interferone γ [IFNγ] circolante totale e dei biomarcatori della sua neutralizzazione, ovvero CXCL9 e CXCL10);
    • Valutare il profilo di altri biomarcatori rilevanti dell’HLH, ad es. sCD25 ed altri biomarcatori esplorativi;
    • Monitorare la potenziale insorgenza di anticorpi anti-farmaco (Anti-Drug Antibodies, ADA).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female pHLH patients, from birth up to and including 18 years at diagnosis of HLH.
    2. A molecular diagnosis or familial history consistent with pHLH or fulfilment of HLH-2004 diagnostic criteria, i.e., five of the eight criteria below:
    - Fever
    - Splenomegaly
    - Cytopenias affecting 2 of 3 lineages in the peripheral blood (hemoglobin <90 g/L; platelets <100 x 109/L; neutrophils <1 x 109/L)
    - Hypertriglyceridemia (fasting triglycerides ≥3 mmol/L or ≥265 mg/dL) and/or hypofibrinogenemia (≤1.5 g/L)
    - Hemophagocytosis in bone marrow, spleen or lymph nodes, with no evidence of malignancy
    - Low or absent natural killer (NK)-cell activity
    - Ferritin ≥500 µg/L
    - Soluble CD25 (sCD25, i.e., soluble IL-2 receptor) ≥2400 U/mL.
    3. Presence of active HLH disease as assessed by the treating physician.
    4. Patients having already received HLH conventional therapy must fulfil one of the following criteria as assessed by the treating physician:
    - Having not responded
    - Having not achieved a satisfactory response
    - Having reactivated
    - Showing intolerance to previous conventional treatment of HLH.
    5. Informed consent signed by the patient (as required by local law), or by the patient’s legally authorized representative(s) with the assent of patients who are legally capable of providing it, as applicable.
    6. Having received guidance on contraception for both male and female patients sexually active and having reached puberty.
    Females of child-bearing potential require use of highly effective contraceptive measures (failure rate of less than 1% per year) from Screening until 6 months after receiving last dose of the study drug.
    Males with partner(s) of child-bearing potential must agree to take appropriate precautions (such as sexual abstinence, barrier contraception, vasectomy) to avoid fathering a child from Screening until 6 months after receiving last dose of study drug.
    1. Pazienti affetti da pHLH di entrambi i sessi, di età compresa tra 0 mesi e 18 anni (inclusi) alla diagnosi di HLH.
    2. Diagnosi molecolare o anamnesi familiare in linea con la pHLH o soddisfazione dei criteri diagnostici HLH-2004, nello specifico di cinque degli otto criteri di cui sotto:
    - Febbre;
    - Splenomegalia;
    - Citopenie che interessano 2 linee su 3 nel sangue periferico (emoglobina <90 g/l; piastrine <100 x 109/l; neutrofili <1 x 109/l);
    - Ipertrigliceridemia (trigliceridi a digiuno ≥3 mmol/l o ≥265 mg/dl) e/o ipofibrinogenemia (≤1,5 g/l);
    - Emofagocitosi nel midollo osseo, nella milza o nei linfonodi, senza evidenza di neoplasia maligna;
    - Attività bassa o assente delle cellule natural killer (NK);
    - Ferritina ≥500 µg/l;
    - CD25 solubile ([Soluble CD25, sCD25], ovvero recettore solubile IL-2) ≥2.400 U/ml.
    3. Presenza di malattia HLH attiva secondo la valutazione del medico curante.
    4. I pazienti già trattati con la terapia standard per l’HLH devono soddisfare uno dei criteri seguenti, in base alla valutazione del medico curante:
    - Assenza di risposta;
    - Risposta insoddisfacente o aggravamento della malattia;
    - Riattivazione della malattia;
    - Intolleranza al precedente trattamento standard per l’HLH.
    5. Consenso informato sottoscritto dal paziente (come disposto dalla normativa locale) o dal/dai suo/i rappresentante/i legalmente autorizzato/i con l’assenso dei pazienti che sono legalmente in grado di fornirlo, a seconda del caso.
    6. I pazienti di entrambi i sessi sessualmente attivi e che hanno raggiunto la pubertà devono aver ricevuto delle linee guida sulla contraccezione.
    Le pazienti fertili devono usare dei metodi anticoncezionali altamente efficaci (con un tasso di fallimento inferiore all’1% annuo) a partire dallo screening e sino a 6 mesi dopo la somministrazione dell’ultima dose del farmaco in studio.
    I soggetti di sesso maschile con partner femminili fertili devono acconsentire ad adottare precauzioni adeguate (quali astinenza sessuale, contraccettivi di barriera, vasectomia) per evitare di concepire un bambino a partire dallo screening e sino a 6 mesi dopo la somministrazione dell’ultima dose del farmaco in studio.
    E.4Principal exclusion criteria
    1. Diagnosis of secondary HLH consequent to a proven rheumatic, metabolic or neoplastic disease.
    2. Active mycobacteria, Histoplasma Capsulatum, Shigella, Salmonella, Campylobacter or Leishmania infections.
    3. Evidence of latent tuberculosis.
    4. Presence of malignancy.
    5. Patients who have another concomitant disease or malformation severely affecting cardiovascular, pulmonary, central nervous system (CNS), liver, or renal function that in the opinion of the Investigator may significantly affect the likelihood to respond to treatment and/or the assessment of emapalumab safety and/or efficacy.
    6. History of hypersensitivity or allergy to any component of the study regimen (e.g., polysorbate).
    7. Receipt of a bacille Calmette-Guerin (BCG) vaccine within 12 weeks prior to Screening.
    8. Receipt of a live or attenuated live (other than BCG) vaccine within 6 weeks prior to Screening.
    9. Pregnant or lactating female patients.
    1. Diagnosi di HLH secondaria conseguente a una malattia reumatica, metabolica o neoplastica comprovata.
    2. Infezioni attive da micobatteri, Histoplasma Capsulatum, Shigella, Salmonella, Campylobacter o Leishmania .
    3. Evidenza di tubercolosi latente.
    4. Presenza di neoplasia maligna.
    5. Presenza di un’altra malattia o malformazione concomitante che colpisce gravemente la funzionalità cardiovascolare, polmonare, epatica, renale o del sistema nervoso centrale (SNC) e che, secondo il parere dello sperimentatore, può significativamente inficiare la probabilità di risposta al trattamento e/o la valutazione della sicurezza e/o efficacia di emapalumab.
    6. Anamnesi di ipersensibilità o allergia a qualsiasi componente del regime di studio (ad es. polisorbato).
    7. Vaccinazione contro il bacillo di Calmette-Guérin (BCG) entro 12 settimane prima dello screening.
    8. Vaccinazione con un vaccino vivo o attenuato (diverso dal BCG) entro 6 settimane prima dello screening.
    9. Pazienti di sesso femminile in gravidanza o in allattamento
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    • Overall Response, i.e., achievement of either Complete or Partial Response or HLH Improvement, at End of Treatment (EOT) or Week 8 (whichever occurs earlier).
    • Risposta complessiva, ovvero raggiungimento di una risposta completa o parziale oppure miglioramento dell’HLH al termine del trattamento (End of Treatment, EOT) o alla Settimana 8 (a seconda di quale evento si verifica per primo).
    E.5.1.1Timepoint(s) of evaluation of this end point
    See E.5.1
    Si veda E.5.1
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    • Overall Survival, including survival to HSCT and survival after either HSCT or last emapalumab infusion (if HSCT is not performed)
    • Event-free Survival
    • Overall Response, i.e., achievement of either Complete or Partial Response or HLH Improvement, at start of conditioning (or at last emapalumab infusion if HSCT is not performed)
    • Duration of Response, ie, maintenance of response achieved any time during the study (with censoring time at start of conditioning for patients with no events)
    • Time to Response at any time during the study
    • Number of patients able to reduce glucocorticoids by 50% or more of baseline dose at any time during emapalumab treatment
    • Number of patients able to proceed to HSCT, when deemed indicated
    • Quality of Life (QOL) indices.

    Safety endpoints:
    • Incidence, severity, causality and outcomes of AEs (serious and non-serious).
    • Evolutions of relevant laboratory parameters, e.g., complete blood cell (CBC) count, liver and renal function tests, and coagulation parameters.
    • Number of patients who discontinued emapalumab treatment for safety reasons.

    PK/PD Endpoints:
    • Serum concentrations of emapalumab to further evaluate emapalumab PK profile.
    • Determination of PD parameters (levels of circulating total IFNγ and markers of its neutralization, namely CXCL9 and CXCL10).
    • Determination of other relevant disease biomarkers, eg, sCD25 and other exploratory biomarkers.
    • Measurement of emapalumab concentrations and PD parameters in other matrices, eg, cerebrospinal fluid (CSF), bronchoalveolar lavage fluid (BALF), if clinically appropriate (exploratory).
    • Level (if any) of circulating antibodies against emapalumab (ADAs).

    Endpoint secondari di efficacia:
    • Sopravvivenza complessiva, comprese la sopravvivenza all’HSCT e la sopravvivenza dopo l’HSCT o dopo l’ultima infusione di emapalumab (se l’HSCT non viene eseguito);
    • Sopravvivenza libera da eventi;
    • Risposta complessiva, ovvero raggiungimento di una risposta completa o parziale oppure miglioramento dell’HLH all’inizio del condizionamento (o all’ultima infusione di emapalumab, se l’HSCT non viene eseguito);
    • Durata della risposta, ovvero mantenimento della risposta ottenuta in qualsiasi momento durante lo studio (censurando al momento dell’avvio del condizionamento per i pazienti che non sperimentano eventi);
    • Tempo alla risposta in qualsiasi momento durante lo studio;
    • Numero di pazienti per i quali la terapia a base di glucocorticoidi può essere ridotta del 50% o più rispetto alla dose al basale in qualsiasi momento durante il trattamento a base di emapalumab;
    • Numero di pazienti in grado di procedere all’HSCT, quando ritenuto indicato;
    • Indici della QOL.
    Endpoint di sicurezza:
    • Incidenza, gravità, causalità ed esiti degli AE (gravi e non gravi);
    • Evoluzioni dei parametri di laboratorio rilevanti, ad es. conta completa delle cellule ematiche (Complete Blood Cell, CBC), test sulla funzionalità epatica e renale e parametri di coagulazione;
    • Numero di pazienti che interrompono il trattamento a base di emapalumab per ragioni di sicurezza.
    Endpoint di PK/PD:
    • Concentrazioni sieriche di emapalumab per valutarne ulteriormente il profilo farmacocinetico;
    • Determinazione dei parametri di PD (livelli di IFNγ circolante totale e dei biomarcatori della sua neutralizzazione, ovvero CXCL9 e CXCL10);
    • Determinazione di altri biomarcatori rilevanti della malattia, ad es. sCD25 ed altri biomarcatori esplorativi;
    • Misurazione delle concentrazioni di emapalumab e dei parametri di PD in altre matrici, ad es. liquido cerebrospinale (Cerebrospinal Fluid, CSF) e lavaggio broncoalveolare (Bronchoalveolar Lavage, BAL), se clinicamente appropriato (per fini esplorativi);
    • Livelli di eventuali anticorpi circolanti contro emapalumab (ADA).
    E.5.2.1Timepoint(s) of evaluation of this end point
    See E.5.2.
    si veda E.5.2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 33
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) Yes
    F. of subjects for this age range: 2
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F. of subjects for this age range: 18
    F.1.1.5Children (2-11years) Yes
    F. of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 3
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F. of subjects incapable of giving consent
    Newborns, infants and toddlers
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 34
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    In case of HLH reactivation (eg transplant failure), the patient will be treated according to the standard of care of the site.
    In caso di riattivazione dell’HLH (ad es. fallimento del trapianto), il paziente sarà trattato secondo lo standard di cura del centro.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-04-28
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